Intas Pharmaceuticals Limited — Gemcitabine Exporter Profile
Indian Pharmaceutical Exporter · #5 for Gemcitabine · $3.8M export value · DGFT Verified
Intas Pharmaceuticals Limited is the #5 Indian exporter of Gemcitabine with $3.8M in export value and 231 verified shipments. Intas Pharmaceuticals Limited holds a 7.9% market share in Gemcitabine exports across 17 countries. The company exports 75 pharmaceutical products worth $372.3M across 19 therapeutic categories.
Intas Pharmaceuticals Limited — Gemcitabine Export Profile: Buyers & Destinations
Where Does Intas Pharmaceuticals Limited Export Gemcitabine?
| Country | Value | Shipments | Share |
|---|---|---|---|
| UNITED STATES | $779.5K | 17 | 34.5% |
| SOUTH AFRICA | $590.3K | 26 | 26.1% |
| NETHERLANDS | $177.1K | 26 | 7.8% |
| POLAND | $156.9K | 16 | 6.9% |
| FRANCE | $98.8K | 2 | 4.4% |
| UNITED KINGDOM | $92.2K | 8 | 4.1% |
| ITALY | $79.9K | 25 | 3.5% |
| SPAIN | $78.6K | 10 | 3.5% |
| BRAZIL | $68.7K | 5 | 3.0% |
| MEXICO | $63.1K | 2 | 2.8% |
Intas Pharmaceuticals Limited exports Gemcitabine to 18 countries. The largest destination is UNITED STATES accounting for 34.5% of Intas Pharmaceuticals Limited's Gemcitabine shipments, followed by SOUTH AFRICA (26.1%) and NETHERLANDS (7.8%). These destinations reflect Intas Pharmaceuticals Limited's established distribution network and regulatory approvals in key markets.
Who Are the Top Buyers of Gemcitabine from Intas Pharmaceuticals Limited?
| Buyer | Country | Value | Orders |
|---|---|---|---|
| EVERSANA LIFE SCIENCES SERVICES,LLC | UNITED STATES | $379.5K | 9 |
| AMERISOURCE HEALTH SERVICES | UNITED STATES | $300.0K | 6 |
| ACCORD HEALTHCARE C/O QESTMED | SOUTH AFRICA | $297.1K | 11 |
| XXCORXXHEAXXHCAXX B XX | NETHERLANDS | $150.0K | 3 |
| TO THE ORDER . | SOUTH AFRICA | $109.1K | 6 |
| EVERSANA LIFE SCIENCES SERVICES LLC | UNITED STATES | $100.0K | 2 |
| TO THE ORDER | MALTA | $94.8K | 14 |
| ACCORD HEALTHCARE C/O QESTMED (PTY) | SOUTH AFRICA | $94.3K | 2 |
| XXCORXXHEAXXHCAXX POXXKA XX ZXX O | POLAND | $91.2K | 2 |
| XXCORXXNL XX XXB | NETHERLANDS | $79.3K | 2 |
Intas Pharmaceuticals Limited supplies Gemcitabine to 50 buyers globally. The largest buyer is EVERSANA LIFE SCIENCES SERVICES,LLC (UNITED STATES), followed by AMERISOURCE HEALTH SERVICES (UNITED STATES) and ACCORD HEALTHCARE C/O QESTMED (SOUTH AFRICA). These buyers represent pharmaceutical distributors, hospital groups, and government procurement agencies in their respective markets.
What Is India's Total Gemcitabine Export Value and How Much Does Intas Pharmaceuticals Limited Contribute?
India exported $36.6M worth of Gemcitabine through 2,938 shipments from 248 suppliers to 125 countries, serving 676 buyers globally. Intas Pharmaceuticals Limited contributes $3.8M to this total, accounting for 7.9% of India's Gemcitabine exports. Intas Pharmaceuticals Limited ships Gemcitabine to 18 countries through 50 buyers.
What Is the Average Shipment Value for Intas Pharmaceuticals Limited's Gemcitabine Exports?
Intas Pharmaceuticals Limited's average Gemcitabine shipment value is $16.6K per consignment, based on 231 shipments totaling $3.8M. The largest destination is UNITED STATES (34.5% of Intas Pharmaceuticals Limited's Gemcitabine exports).
How Does Intas Pharmaceuticals Limited Compare to Other Indian Gemcitabine Exporters?
Intas Pharmaceuticals Limited ranks #5 among 248 Indian Gemcitabine exporters with a 7.9% market share. The top 3 exporters are FRESENIUS KABI ONCOLOGY LIMITED ($6.9M), EUGIA PHARMA SPECIALITIES LIMITED ($5.9M), SUN PHARMACEUTICAL INDUSTRIES LIMITED ($5.8M). Intas Pharmaceuticals Limited processed 231 shipments to 17 destination countries.
What Gemcitabine Formulations Does Intas Pharmaceuticals Limited Export?
| Product Description / Formulation | Value | Shipments |
|---|---|---|
| PHARMA DRUGS & MEDI GEMCITABINE RTU 100M | $255.1K | 8 |
| PHARMA DRUGS & MEDI ACCORD -GEMCITABINE | $94.3K | 2 |
| PHAR.DRUGS AND MED: CYTIGEM 200 EACH VIAL CONTAINS: GEMCITABINE HYDROCHLORIDE EQ.TO 200MG GEMCITABINE FREE BASE | $83.5K | 4 |
| GEMCITABINE100MG/ML 20ML | $81.6K | 3 |
| PHARMA DRUG&MED:ACCORD -GEMCITABINE 1G E | $71.9K | 3 |
| GEMCITABINE 100MG/ML20ML RTUACCORD-FRAN | $51.0K | 2 |
| PHR DRUGS&MEDI GEMCITABINE RTU 100MG/ML, | $50.8K | 3 |
| PHARMA DRUG&MED: CYTIGEM 1000 EACH VIALCONTAINS: GEMCITABINE HYDROCHLORIDE EQ.TO 1G GEMCITABINE FREE BASE | $50.5K | 4 |
| PHR DRUGS&MEDI GEMCITABINE RTU 100MG/ML | $50.0K | 1 |
| GEMCITABINE 100MG/ML20ML | $50.0K | 1 |
Intas Pharmaceuticals Limited exports 147 distinct Gemcitabine formulations including tablets, capsules, syrups, and combination drugs. The top formulation is PHARMA DRUGS & MEDI GEMCITABINE RTU 100M with 8 shipments worth $255.1K. Notable combination products include fixed-dose combinations with other active ingredients, meeting diverse global regulatory requirements.
Regulatory Requirements: Exporting Gemcitabine to Key Markets
What Intas Pharmaceuticals Limited must comply with to export Gemcitabine to its top destination countries
United States — FDA
Approval Process
ANDA (Abbreviated New Drug Application) for generics. Indian manufacturing site must pass FDA pre-approval inspection. Drug Master File (DMF) required for APIs.
Timeline: 10–18 months for ANDA approval
GMP & Export Requirements
FDA cGMP compliance (21 CFR 210/211); facility inspection by FDA
Drug Listing with FDA; Export Certificate from CDSCO India; Import Alert screening via FDA PREDICT system
Note: Subject to FDA Import Alerts. Open Form 483 observations can block all exports from a facility.
South Africa — SAHPRA
Approval Process
Registration under SAHPRA guidelines (CTD format). Bioequivalence required for generics.
Timeline: 24–48 months (significant backlog)
GMP & Export Requirements
WHO GMP or PIC/S GMP compliance
Certificate of Pharmaceutical Product from CDSCO; Import permit per Section 22A of Medicines Act
Note: Known registration backlog. WHO Prequalification significantly assists the process.
Regulatory information is provided for general reference based on publicly available guidelines. Requirements vary by formulation, dosage form, and therapeutic classification. Exporters should consult qualified regulatory affairs professionals for case-specific guidance.
How Does Intas Pharmaceuticals Limited Compare to Nearest Gemcitabine Exporters?
Exporters ranked immediately above and below #5 by export value
| # | Supplier | Export Value | Shipments | Countries | Avg/Shipment |
|---|---|---|---|---|---|
| 2 | EUGIA PHARMA SPECIALITIES LIMITED | $5.9M | 188 | 2 | $31.4K |
| 3 | SUN PHARMACEUTICAL INDUSTRIES LIMITED | $5.8M | 137 | 3 | $42.3K |
| 5 | INTAS PHARMACEUTICALS LIMITED ★ | $3.7M | 231 | 17 | $16.0K |
| 6 | ACCURE LABS PRIVATE LIMITED | $3.1M | 107 | 2 | $29.0K |
| 9 | VENUS REMEDIES LIMITED | $2.2M | 189 | 23 | $11.6K |
Intas Pharmaceuticals Limited ranks #5 among 248 Indian Gemcitabine exporters. Average shipment value of $16.0K compared to the market average of $147.4K. The closest competitors by value are EUGIA PHARMA SPECIALITIES LIMITED and SUN PHARMACEUTICAL INDUSTRIES LIMITED.
Which Indian Ports Ship Gemcitabine Exports?
| Port | Shipments | % Share |
|---|---|---|
| DELHI AIR CARGO ACC (INDEL4) | 538 | 18.3% |
| SAHAR AIR CARGO ACC (INBOM4) | 393 | 13.4% |
| SAHAR AIR | 370 | 12.6% |
| DELHI AIR | 358 | 12.2% |
| Delhi Air | 131 | 4.5% |
| HYDERABAD ICD (INSNF6) | 88 | 3.0% |
| Bombay Air | 77 | 2.6% |
| NHAVA SHEVA SEA (INNSA1) | 66 | 2.2% |
What Other Oncology Products Does Intas Pharmaceuticals Limited Export?
Intas Pharmaceuticals Limited also exports these oncology products. Each links to the detailed product page.
Geopolitical & Trade Policy Impact on Intas Pharmaceuticals Limited's Gemcitabine Exports
The current geopolitical landscape presents both challenges and opportunities for Indian pharmaceutical exporters like Intas Pharmaceuticals. The Israel-Iran tensions have led to increased security risks in the Strait of Hormuz and the Red Sea–Suez Canal corridor, prompting major carriers to reroute shipments around the Cape of Good Hope. This detour has extended transit times by 10–20 days and raised freight rates by 40–50% on key India–Europe routes, impacting the cost-effectiveness and timeliness of exports. (livemint.com)
Conversely, the ongoing US-China trade tensions have opened avenues for Indian pharmaceutical companies to capture a larger share of the U.S. market. Intas's acquisition of UDENYCA® and the FDA's acceptance of its biosimilar applications position the company to leverage these opportunities effectively. However, compliance with the European Union's Falsified Medicines Directive (FMD) remains a critical factor for market access. Intas's proactive approach in securing partnerships and ensuring regulatory compliance underscores its commitment to maintaining and expanding its presence in the European market.
Intas Pharmaceuticals Limited — Regulatory Compliance & Quality Standards
Maintaining stringent regulatory compliance is paramount for Indian pharmaceutical exporters. Intas Pharmaceuticals has demonstrated a strong commitment to adhering to international quality standards, as evidenced by its successful acquisitions and partnerships that necessitate compliance with FDA, WHO, and EU Good Manufacturing Practices (GMP). The company's proactive engagement in regulatory processes, such as the FDA's acceptance of its Biologics License Application for DMB-3115, reflects its dedication to quality and compliance. (intaspharma.com) As global regulatory requirements continue to evolve, Intas's focus on quality assurance and compliance positions it favorably in the competitive pharmaceutical export market.
About Intas Pharmaceuticals Limited
Intas Pharmaceuticals Limited exports 75 products worth $372.3M. Beyond Gemcitabine, top products include Ras, Mycophenolate, Tacrolimus, Apixaban, Ezetimibe. View the complete Intas Pharmaceuticals Limited profile for full portfolio analysis.
Market Intelligence
Latest developments and market context
Detailed market intelligence for Gemcitabine — including regulatory updates, trade policy changes, and competitive landscape analysis — will be available in an upcoming update. This section will feature AI-researched insights from verified industry sources, government notifications, and market reports.
Official References & Regulatory Resources
- CDSCO India
- Pharmexcil
- IBEF — India Pharma Industry
- Ministry of Commerce — Pharma Exports
- India Trade Statistics (DGFT)
Verify manufacturer licensing and export certifications with the official agencies above.
Research Methodology & Data Transparency
Suresh Sormare
Verified AuthorPharmaceutical Export-Import Analyst & Trade Intelligence Expert
Suresh Sormare is a pharmaceutical export-import analyst with deep expertise in Indian Customs (DGFT) data, HS code classification, and global pharmaceutical supply chains. His analysis covers 10M+ shipment records across 150+ countries and is used by manufacturers, procurement agencies, and trade consultants worldwide. Suresh specializes in identifying verified suppliers and buyers from customs records, mapping bilateral pharmaceutical trade corridors, analyzing tariff structures and regulatory frameworks across 170+ destination markets, and benchmarking competitive positioning for finished pharmaceutical formulations. His methodology combines granular customs transaction data with regulatory intelligence from FDA, EMA, WHO, CDSCO, and 40+ national drug authorities to deliver actionable trade insights for the pharmaceutical formulations sector.
linkedin.com/in/sureshsormarePrimary Data Source
All trade data is sourced from Indian Customs (DGFT) official shipping bill records — the authoritative government database for India's pharmaceutical trade. Each verified record contains exporter name, consignee (buyer) name, detailed product description, quantity, declared FOB value (USD), port of loading, destination country, and shipment date.
Analysis Methodology
- 1.Product Matching: Gemcitabine shipments identified using fuzzy matching on DGFT product description fields, validated against Indian Pharmacopoeia nomenclature.
- 2.Supplier Identification: Intas Pharmaceuticals Limited matched across shipments using name normalization, accounting for company name formatting variations.
- 3.Statistical Normalization: Shipment values are statistically normalized to ensure accurate market share representation. This removes the impact of unusually large one-off transactions that could distort company rankings.
- 4.Verified Records: This page is backed by 234 individual customs records matching Intas Pharmaceuticals Limited exporting Gemcitabine, covering 147 formulations to 18 countries via 50 buyers.
Government-Sourced Data
Official DGFT customs records
Transparent Methodology
Calculations fully disclosed above
Global Coverage
Exports to 125+ countries, 676+ buyers
Expert-Reviewed
Analyzed by pharmaceutical trade specialists
Get Gemcitabine Export Data from Intas Pharmaceuticals Limited
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Intas Pharmaceuticals Limited
Full Company Profile →
75 products · $372.3M total trade · 19 categories
Gemcitabine Stats
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Trade data sourced from Indian Customs (DGFT) export shipment records. Values represent FOB export value in USD. Market share calculated relative to total Indian pharmaceutical exports for Gemcitabine. For current shipment-level data, contact TransData Nexus.